Effect Evaluation of Different Blood Products Infusion on Neonatal Anemia

Neonatal Anemia Clinical Trial

Official title:

Effect Evaluation of Different Blood Products Infusion on Neonatal Anemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06285604
• Other study ID #: IRB-20230398-R
• Status: Not yet recruiting
• Start date: March 30, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Women's Hospital School Of Medicine Zhejiang University
• Contact: Guangyong Ye
• Phone: +8613516803338
• Email: ygy20518158[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to evaluate the clinical efficacy of the transfusion of irradiated red blood cells, washed red blood cells, and leukocyte privative red blood cells, and to study the changes of inflammatory response before and after the transfusion of irradiated red blood cells, washed red blood cells, and leukocyte privative red blood cells in anemic neonates. The main questions it aims to answer are:

• Objective evaluation of the advantages and disadvantages of transfusion of different blood products in the treatment of neonatal anemia from the clinical efficacy.

• To provide objective basis for clinical rational use of blood in the selection of blood products.

Participants will be transfused with fresh irradiated red blood cells, washed red blood cells, and leukocyte privative red blood cells respectively according to relevant clinical and laboratory indicators.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 1 Year

Eligibility

Inclusion Criteria:

Neonates with stable hemodynamics who need blood transfusion are comprehensively evaluated by neonatologists according to their clinical conditions (heart, respiratory status, postnatal age, pregnancy at birth), laboratory indicators, etc. Diagnosis of Neonatal Septicemia:

• The mother had chorioamnionitis infection or Premature rupture of membranes (PROM) =18 h.

• The clinical diagnosis is that there are clinical abnormal manifestations, and any of the following conditions is met at the same time: ? blood non-specific examination = 2 items are positive, ? cerebrospinal fluid examination is purulent meningitis change, and ? pathogenic bacteria DNA is detected in blood.

• The diagnosis was confirmed as having clinical manifestations and positive blood culture or cerebrospinal fluid (or other sterile cavity fluid) culture.

Exclusion Criteria:

• Infants with necrotizing enterocolitis (NEC) (current or previous).

• Feeding intolerance (defined as the decision of the treatment clinical team to suspend feeding / suspend feeding for at least 12 hours).

• RBC transfusion in the past 72 hours; Children who received ibuprofen / indomethacin / surgery 72 hours ago and / or severe congenital malformations such as congenital gastrointestinal tract, complex cardiopulmonary / fatal abnormalities or need emergency blood transfusion.

Related Conditions & MeSH terms

• Anemia
• Anemia, Neonatal
• Neonatal Anemia

Intervention

Procedure:
• Blood transfusion
Transfusion of designated red blood cell products to anemic neonates.

Locations

Country	Name	City	State
China	Women's Hospital School of Medicine Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Women's Hospital School Of Medicine Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical efficacy of different red blood cell products transfusion in anemic neonates	The changes of hemoglobin concentration, crSo2 and cFTOE before and after transfusion were detected to evaluate the effects of different red blood cell products on brain oxygenation capacity of anemic neonates.	The test results of each subject before and 24 hours after blood transfusion were analyzed.
Primary	The changes of inflammatory response before and after transfusion in anemic neonates	IL-6, IL-10 and CRP levels were measured, and the effect of infusion of different red blood cell products on the potential inflammatory response of anemic neonates was evaluated.	The test results of each subject before and 24 hours after blood transfusion were analyzed.